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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008 Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Atrial Tachycardia (1731); Death (1802); No Code Available (3191)
Event Date 05/08/2013
Event Type  Death  
Event Description

The following was reported by the user facility to the manufacturer on (b)(4) 2013. The pt had complaints of chills and tachycardia during treatment. Pt requested to end hemodialysis early. Pt became unresponsive, 911 activated. Cpr performed. Pt transferred to the emergency room via ems. Pt expired at the hospital. On (b)(4) 2013, the manufacturer received a user facility medwatch form that reported the same event as noted above.

 
Manufacturer Narrative

On (b)(4) 2013, technical support received a call from user facility for request of machine evaluation following adverse event during dialysis (chills, tachycardia). Medical records were reviewed. On (b)(6) 2013, the hemodialysis treatment started at 10:20 am. The pre-treatment vital signs were: blood pressure 142/76, temperature: 98. 4 f, weight: (b)(6). At 12:35, the pt complained of chills and at that time the pt's pulse was 121, temperature: 98. 7 f with uf removed of 419 ml. The treatment was interrupted abruptly at 12:45 because the pt was found unresponsive. Cpr was initiated, aed was placed and a shock was delivered. Normal saline 900 mls given. The pt remained apneic. Ems continued cpr and intubated the pt with an endotracheal tube. Iv epi x3 were given. The heart monitor showed coarse ventricular fibrilation. The pt expired at 13:43 pm that day. Based on the medical records provided, it is unknown whether the device may have caused or contributed to the reported event. Although medical records were provided, the exact cause of death is unknown and the er admission was not provided. Additionally, an autopsy report or death certificate has not been provided. Currently, the manufacturing plant investigation is still on-going. A supplemental report will be submitted when the plant investigation is complete. Reference mdr #'s 1713747-2013-99908, 8030665-2013-00368, 1713747-2013-00181, 2937457-2013-00076, 3005162618-2013-00009.

 
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Brand NameFRESENIUS COMBISET 2008
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
Manufacturer Contact
ronald tokozy, rn, bsn, cnn, jd
920 winter street
MDR Report Key3164029
MDR Text Key3447581
Report Number8030665-2013-00368
Device Sequence Number1
Product Code FJK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 05/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/10/2013
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/07/2013 Patient Sequence Number: 1
Treatment
FRESENIUS HEMODIALYSIS MACHINE 2008 K2; FRESENIUS NORMAL SALINE; FRESENIUS DIALYSATE (2K 2.5CA); FRESENIUS DIALYZER OPTIFLIX 160NRE
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